ECMO
Conditions
Brief summary
ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.
Interventions
DRUGNafamostat
Nafamostat combined with unfractionated heparin for anticoagulation
DRUGHeparin
unfractionated heparin for anticoagulation
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age older than 18 years old * received VV ECMO because of severe respiratory failure
Exclusion criteria
* anticoagulant contraindications * cerebral infarction or suspected patients * severe hypertension * women in gestational and lactational period * hemophilia * allergic to heparin or Nafamostat * unwilling or unable to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of ECMO related bleeding or thrombotic events | 28 days | the incidence of ECMO related bleeding or thrombotic events,such as membrane oxygenator or tube thrombotic,local blooding. |
Secondary
| Measure | Time frame |
|---|---|
| Types and specific incidence rates of ECMO-related bleeding and thrombotic events | 28 days |
| Time from ECMO initiation to bleeding and thrombotic events | 28 days |
| ECMO duration | 28 days |
| Blood product transfusion | 28 days |
| Mortality | 60 days |
Countries
China
Contacts
CONTACTBing Sun, MD
PRINCIPAL_INVESTIGATORBing Sun, MD
Beijing Chao Yang Hospital
Outcome results
None listed